Tocilizumab does not ease signs or forestall dying in reasonably sick COVID-19 inpatients
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The drug tocilizumab (Actemra) does not reduce the need for respiratory support with mechanical ventilation or prevent death in moderately ill hospitalized patients with COVID-19, according to a new study conducted by Massachusetts General Hospital (MGH) researchers. The study, published in the New England Journal of Medicine (NEJM), casts doubt on previous research suggesting that tocilizumab, commonly prescribed for rheumatoid arthritis (RA) and other conditions, may be an effective treatment for patients with worsening COVID- Cases could be -19.
About 15 percent of patients with COVID-19 develop severe cases. These patients typically develop pneumonia, which lowers the levels of oxygen in the blood and requires hospitalization. There is some evidence that this life-threatening condition can be caused by what is known as a “cytokine storm,” in which the immune system releases an abnormally high volume of inflammatory cells, which normally damage the lungs and require additional treatment with oxygen.
“Markers of inflammation in peripheral blood are elevated at sky high levels,” says MGH rheumatologist John H. Stone, MD, MPH, who was the lead researcher on the NEJM study. COVID-19 patients with elevated levels of a cytokine called interleukin-6 (IL-6) have greater needs for supplemental oxygen, which is provided by mechanical ventilation, and a higher risk of death.
The drug tocilizumab blocks IL-6. Stone previously conducted clinical trials that led to the approval of tocilizumab for the treatment of another inflammatory disease: giant cell arteritis. Several previous studies suggested that tocilizumab might benefit COVID-19 patients, although no randomized, double-blind, placebo-controlled (“gold standard”) studies were required to confirm this hypothesis. The NEJM study, conducted by MGH researchers and conducted by a group of seven hospitals during the height of the pandemic, has been called the Boston Area COVID-19 Consortium (BACC) Bay Tocilizumab Study.
The study included 243 hospitalized patients with moderate cases of COVID-19 who had high levels of inflammation and at least two of the following symptoms: pneumonia, low blood oxygen, and fever. Two-thirds of the participants received an infusion of tocilizumab, while the remaining patients received a placebo in addition to standard care. Most of the affected patients received supplemental oxygen through a nasal tube or cannula. The main aim of the study was to find out whether tocilizumab prevented recipients from eventually needing respiratory assistance, delivered from a ventilator through a tube inserted in the mouth (intubation), or died.
The study found that patients treated with tocilizumab were just as likely as those given placebo infusions to require intubation or to die over four weeks. Likewise, the patients’ conditions improved or worsened at the same rate in both groups.
“We have shown very clearly that the use of IL-6 receptor blockade is not warranted in patients with the severity of the disease we studied,” says Stone, noting that other studies with tocilizumab given to patients who have already been intubated have found no use either. It’s possible the drug may help COVID-19 patients whose severity is somewhere between that of those enrolled in the BACC Bay study and those who are already on mechanical ventilation, Stone says. Studies on this issue are ongoing.
Survival with tocilizumab in ventilated COVID-19 patients
New England Journal of Medicine (2020). DOI: 10.1056 / NEJMoa2028836 Provided by Massachusetts General Hospital
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